Clearance Summary
IDECAP DIALYZER received FDA 510(k) clearance under submission number K852764, sponsored by Trans-National Trade Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1985-09-20.
- Submission: K852764
- Applicant / Sponsor: Trans-National Trade Development Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5830
- Decision date: 1985-09-20
Classification & Regulation
This clearance is catalogued under FDA product code FJH and 21 CFR 876.5830, within the Gastroenterology, Urology review panel as a Class II device.